CITI Training Practice Exam

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What document includes information necessary for potential subjects to provide informed consent to participate in a clinical trial?

Trial Synopsis
Informed Consent Document
Study Overview
Participant Information Sheet

The correct answer is: Informed Consent Document

Informed consent is a crucial part of the ethical conduct of a clinical trial, as it ensures that participants understand the potential risks and benefits of the study before agreeing to participate. Option A, Trial Synopsis, refers to a summary of the trial protocol and does not include all necessary information for informed consent. Option C, Study Overview, may provide a general understanding of the trial but will not have as much detail as the actual Informed Consent Document. Option D, Participant Information Sheet, may contain some important information, but it is not as comprehensive as the Informed Consent Document, which requires potential subjects to sign and date it to indicate their agreement to participate. Therefore, option B is the most appropriate choice for a document that includes all necessary information for potential subjects to provide informed consent to participate in a clinical trial.